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Electronic Batch Records

For pharmaceutical, medical device, and manufacturing companies, accountability is an important component of quality management - and FDA and ISO compliance. Electronic batch records demonstrate accountability by providing proof of proper handling of every significant step in the production of each batch of a product. In addition, FDA regulated companies that execute and document batch records electronically must comply with the FDA's 21 CFR Part 11 requirements and good manufacturing practices.

How can the MasterControl Electronic Batch Records™ EBR System Benefit You?

MasterControl Electronic Batch Records, designed based on the instrumentation, systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes. This automated EBR system will help ensure GMP compliance and increase efficiency in creating and managing master recipes and control recipes. For manufacturers automating their paper-based batch record systems for the first time, MasterControl meets all software-related requirements of Part 11.

Here's how the MasterControl electronic batch records management system addresses some of the major challenges that companies face in their batch record systems.

MasterControl electronic batch records automate routing, follow-up, and escalation of batch records for more efficient process management. Pre-configured forms simplify data collection and help minimize errors common in manual data collection. The electronic in-box tracks all active tasks for a user and provides the tools to stay up-to-date. This automated EBR system is based on the S88 standard, providing an FDA-compliant framework to model a wide range of manufacturing processes.

Poor Tracking

Without an electronic batch records system, physically tracking logs, test results, and other records from different areas is time-consuming. A manual process makes it almost impossible to avoid bottlenecks, a serious problem in case of a need to identify defective batches.

Automatic Tracking

MasterControl tracks all routing information and data entered into the electronic batch records form, allowing the batch coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing.

Disconnected Processes

Under a paper-based or a partially automated EBR system, data are kept in different repositories that are disconnected, making reporting, trending, and analysis difficult.

Connected EBR System Processes

This automated EBR system is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. For example, production data can be correlated to deviations, material nonconformances, and customer complaints. Through its robust analytics capability, MasterControl leverages all data collected by the system for use in continuous quality improvement.

Features of Electronic Batch Records

The MasterControl EBR management system is an ideal solution for automating and optimizing management of batch records. Below is a summary of its key features.

Framework for Master Recipes and Control Recipes: This automated electronic batch records solution creates a flexible framework to model a wide range of manufacturing processes in accordance with the S88 model for electronic batch records. It can handle a mix of parallel and sequential processing steps or unit procedures under the same recipe. The system helps ensure the capture of all data critical to GMP compliance in the following documents:

Master Recipes (the documents that outline the details of a manufacturing process).

Control Recipes (authorized copies of the currently effective Master Recipe that governs an individual manufacturing run).

Best-Practice Forms and Process : MasterControl's automated EBR system provides a set of four pre-configured, multi-page forms that instruct users on the manufacturing steps and allows them to record all relevant data.

Each step is electronically signed by a performer and a witness, in accordance with industry-standard documentation practice.

This electronic batch records management solution helps enforce processes involving serial steps by requiring users to complete recording and verification of information before moving on to the next step.

Integrated with the Deviation Process: Every manufacturing process needs a mechanism to deviate from the prescribed procedure, but controls have to be in place to ensure that a deviation is acceptable. MasterControl Deviations™ can be integrated to electronic batch records that seamlessly integrate the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process. Deviations also serve as the link to other MasterControl quality management modules such as MasterControl Nonconformance and MasterControl CAPA.

Form-to-Form Launching: A Control Recipe can be created through form-to-form launching from a Master Recipe form. This allows relevant data to be transferred automatically from one form to the other, linking the forms and reducing manual data entry. By the same mechanism, a Deviation form can be launched from a Control Recipe form, triggering a separate quality review process.

Analytics Reporting Tool: The MasterControl electronic batch records has a built-in analytics tool that comes with a standard set of pre-configured reports that can be adjusted and customized by the end user. Production records can be trended and analyzed by product, recipe, etc. These "data-mining" capabilities can give important insights into overall production activities such as turnaround, quality issue rates, etc.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.